Acupuncture Safety in Diabetic Limb: A Scoping Review

Abstract

Background:

Any injury to the diabetic limbs may portent disastrous consequences. However, it is not uncommon for diabetics to also seek complementary and alternative medicine for treatment, such as acupuncture. There are limited data on infective or ulcerative adverse events regarding acupuncture in diabetic limbs.

Objective:

This scoping review served to survey and map out the current literature landscape on infective or ulcerative complications, if any, of acupuncture in diabetic limbs and to also identify key gaps in the current literature.

Methods:

A scoping review was conducted based on the five-step framework by Arskey and O’Malley. The review included a comprehensive search of three databases (PubMed, Medline, and Embase) regarding any reports of adverse events after acupuncture in diabetic limbs.

Results:

Eight articles were analyzed. Four were case reports, three were clinical trials, and one was a review article. Most of the articles mentioned qualifications for practitioners (except for two articles). Clean needle technique was mentioned only in one article. Three articles highlighted adverse events and possible dangers related to needling in diabetic limbs. The other five articles highlighted no serious adverse events in using acupuncture/needling in diabetic limbs.

Conclusions:

While there are risks of ulceration and poor healing after acupuncture in diabetic feet, there are also likely benefits like improving neuropathy symptoms and ulcer healing. It is important to optimize safety risk factors such as procedural sterility, avoiding concomitant heat modalities, and ensuring qualified practitioners. Only then can patients benefit from acupuncture treatment for diabetic feet while minimizing complication rates.

INTRODUCTION

Diabetes is one of the most prevalent chronic diseases in the world, with a global diabetes prevalence of 8.8%, or roughly 1 in 11 adults having diabetes, making it a global health emergency.¹ Poorly controlled diabetes results in a plethora of macrovascular and microvascular complications, of which poor wound healing in the extremities is one of the most debilitating sequelae. Any disruption to the skin barrier and subsequent injury in the diabetic foot can portent disastrous consequences, from infection to gangrene and amputation.² As such, it is imperative for meticulous foot care in diabetics to avoid injury.³ Diabetics, however, may seek complementary and alternative medicine for treatment, especially acupuncture.⁴ At present, to our best knowledge, there are limited data on infective or ulcerative complications and adverse events regarding acupuncture in diabetic limbs. This scoping review aimed to survey and map out the current literature landscape regarding infective or ulcerative complications of acupuncture in diabetic limbs. This review also served to identify key gaps in the current literature.

METHODS

A scoping review was conducted based on the five-step framework by Arskey and O’Malley.⁵ These steps consist of (i) identifying the research objective(s), (ii) identifying the relevant studies, (iii) selecting the studies, (iv) charting the relevant data, and (v) collating, summarizing, and reporting the results. The review included a broad search of the literature pertaining to any complications or adverse events of the use of acupuncture in diabetic limbs. This scoping review had been registered with the Open Science Framework (https://osf.io/trjyp). Reporting followed the PRISMA Extension for Scoping Reviews checklist.⁶

Identifying the Research Objectives

The following research objectives were developed to determine the eligibility criteria, guide the scope of the review, and establish an effective search strategy:

• 1.Consensus was obtained amongst all three reviewers defining the scope of the articles that detail the use of acupuncture in diabetic limbs and the documentation of complications, if any;
• 2.Creation of robust inclusion and exclusion criteria;
• 3.Understanding the data collection methods, collating and summarizing relevant information; and
• 4.Synthesis of suitable outcome measures that showed the presence or absence of infective/ulcerative complications or adverse events post acupuncture in diabetic limbs.

Identifying the Relevant Studies

Inclusion and exclusion criteria were developed to identify the relevant studies.

The inclusion criteria were:

• a)Studies with acupuncture or needling (moxa-attached acupuncture and electro-acupuncture inclusive) that breached the skin barrier in the diabetic limbs and documentation of infective/ulcerative adverse events or the absence of it;
• b)Studies in English and Chinese language.

The following exclusion criteria were applied during the search process:

• a)Studies involving pediatric population (age 18 years and below);
• b)Studies that used acupuncture or needling that did not breach the skin barrier, for example, laser acupuncture;
• c)Studies using any other forms of complementary and alternative medicine other than acupuncture or needling, for example: herbal medicine, moxibustion without acupuncture/needling
• d)Studies using Western medical modalities, for example, drug-eluting needles, needle tenotomy, percutaneous electrical stimulation, and platelet-rich plasma injections
• e)Non-human and cadaveric studies; and
• f)Poster or conference oral presentations.

Data Sources and Search Strategies

A comprehensive search was undertaken to identify published studies in three databases, namely PubMed, Medline, and Embase, from inception to 25 November 2024. The search terms in each database are depicted in Table 1. Keywords related to acupuncture, needling, diabetes, wounds, and ulcers were used in the search.

Table 1.

Search Terms

Search terms (pubmed)	Search terms (MEDLINE)	Search terms (EMBASE)
(“acupunctural”[All Fields] OR “acupuncture”[MeSH Terms] OR “acupuncture”[All Fields] OR “acupuncture therapy”[MeSH Terms] OR (“acupuncture”[All Fields] AND “therapy”[All Fields]) OR “acupuncture therapy”[All Fields] OR “acupuncture s”[All Fields] OR “acupunctured”[All Fields] OR “acupunctures”[All Fields] OR “acupuncturing”[All Fields] OR (“needle s”[All Fields] OR “needled”[All Fields] OR “needles”[MeSH Terms] OR “needles”[All Fields] OR “needle”[All Fields] OR “needlings”[All Fields] OR “percutaneous collagen induction”[MeSH Terms] OR (“percutaneous”[All Fields] AND “collagen”[All Fields] AND “induction”[All Fields]) OR “percutaneous collagen induction”[All Fields] OR “needling”[All Fields])) AND (“diabete”[All Fields] OR “diabetes mellitus”[MeSH Terms] OR (“diabetes”[All Fields] AND “mellitus”[All Fields]) OR “diabetes mellitus”[All Fields] OR “diabetes”[All Fields] OR “diabetes insipidus”[MeSH Terms] OR (“diabetes”[All Fields] AND “insipidus”[All Fields]) OR “diabetes insipidus”[All Fields] OR “diabetic”[All Fields] OR “diabetics”[All Fields] OR “diabets”[All Fields]) AND (“ulcer”[MeSH Terms] OR “ulcer”[All Fields] OR “ulcerate”[All Fields] OR “ulcerated”[All Fields] OR “ulcerates”[All Fields] OR “ulcerating”[All Fields] OR “ulceration”[All Fields] OR “ulcerations”[All Fields] OR “ulcerative”[All Fields] OR “ulcers”[All Fields] OR “ulcer s”[All Fields] OR “ulcerous”[All Fields])	((acupuncture or needling) and diabetes and wound).af.	((acupuncture or needling) and diabetes and ulcer).af.

Study Selection

Following removal of duplications, two reviewers (YY) and (WH) independently screened all titles and abstracts. Eligible titles and abstracts were included in the full text review, which was again screened by (YY) and (WH) against the eligibility criteria. For any disagreement between (YY) and (WH), a third reviewer (HY) had the casting vote.

Data Extraction, Charting, Collating, and Reporting of the Results

Descriptive information (including author, year, language, country of origin, type of study, type of intervention, practitioner and needle used, intervention frequency and duration, sterility of procedure and site of intervention) was summarized (Table 2). Outcomes pertaining to the presence or absence of infective/ulcerative complications were summarized descriptively in Table 3.

Table 2.

Study Characteristics

Author/year/ Language	Country	Type of study	No. of patients (n)	Type of intervention	Type of practitioner	Type of needle	Intervention frequency and duration	Sterility of procedure	Indication for intervention	Site of intervention
Case report
Saw 20047 English	Malaysia	Case report	1	Acupuncture	Acupuncturist	Filiform needle	Unknown	Single needle over flame. Nil skin disinfection	Knee osteoarthritis	Knee
Ede 20088 English	UK	Case report	1	Acupuncture	Unknown	Filiform needle	Unknown	Unknown	Neuropathic foot pain	Foot Metatarsal
He 20189 Chinese	China	Case report	1	Acupuncture	Acupuncturist	Warm Acupuncture (moxa attached filiform needles)	Once a day for one week	Unknown	Knee pain in diabetic	Knee
F Qi 202210 English	China	Case study	2	Fu’s subcutaneous needling (FSN)	Unknown	Fu’s subcutaneous needle	Case 1: 6 sessions of FSN in 8 days Case 2: 10 sessions of FSN in 14 days	Unknown	Diabetic necrotic foot ulcer	Calf region
Clinical trials
Bailey 201711 English	USA	Pragmatic effectiveness study	25	Acupuncture	Acupuncturist	Unknown	30 mins acupuncture session. Once per week for 10 weeks.	Unknown	Diabetic peripheral neuropathy and pain	Lower Limb
Z Qi 201812 English	China	Pragmatic clinical trial	126	Acupuncture + Hydrotherapy	Acupuncturist	Filiform needle	30 mins acupuncture session. Once every two days for 15 weeks	Unknown	Diabetic lower-extremity artery disease	Lower Limb and some upper limb points
Sang 202413 English	China	Randomised control trial	380	Electro-acupuncture	Certified practitioners	Filiform needle	30 mins acupuncture session. Two sessions per week for 12 weeks	Sterile single use needles used	Diabetic foot ulcers	Lower limb
Review
Liu 202214 English	China	Review article	NA	Acupuncture	NA	NA	NA	NA	Diabetic foot ulcers	NA

Table 3.

Outcomes

Author/year	Type of study	Outcome
Adverse events
Saw 20047	Case report	Complication of necrotising fasciitis after acupuncture to right knee. Required surgical drainage and intravenous antibiotics.
Ede 20088	Case report	Single 1.0 cm acupuncture needle fragment found buried in foot over second metatarsal. Complication of foot ulcers and toe gangrene which required surgical debridement and subsequent below knee amputation.
He 20189	Case report	Localised infection of treatment region requiring incision and drainage, oral antibiotics.
Nil adverse events
F Qi 202210	Case study	Healing of foot ulcers and infection in both cases. Nil adverse events post needling.
Bailey 201711	Pragmatic effectiveness study	19 of 25 study participants reported a significant reduction in the Neuropathy Total Symptom Scale. Nil adverse events post acupuncture.
Z Qi 201812	Pragmatic clinical trial	Combination of acupuncture with hydrotherapy improved leg flow conductance and physical function. Reduction of dyslipidemia, inflammatory markers and stabilizing oxidative factors were noted. Nil reports of risks of skin bruise, ulceration, or development of Charcot joint.
Sang 202413	Randomised Control Trial	Electroacupuncture group had significantly greater reduction in wound size, reduced pain scores and higher Quality of Life scores. Adverse events of bleeding and pain at treatment site was significant. Infection was present in both treatment and control groups without significant differences.
Liu 202214	Review article	Summarised benefits of acupuncture for diabetic foot: therapeutic effects and preventive effects. Nil adverse events mentioned.

RESULTS

Selection of Articles

The search produced 206 initial publications, with 110 from PubMed, 75 from Embase, 20 from Medline. and 1 article from an additional search. There were 15 duplicates removed, with 191 publications remaining. There were 182 publications that did not meet the inclusion criteria, leaving 9 retrieved for the screening. Of the remaining nine, there was one article excluded after full-text screening because it did not use acupoints on the limbs, leaving eight studies as the final number for analysis (Fig. 1).

FIG. 1.

PRISMA Flow Chart.

Study Characteristics

As seen in Table 2, of the eight selected articles, four were case reports, three were clinical trials, and one was a review article. All were in English except for one. Five articles were from China and one each from Malaysia, the UK, and the United States of America, respectively. For the type of needling, all the articles involve traditional acupuncture except for one, which used a form of subcutaneous needling (Fu’s subcutaneous needling). Most of the case reports and clinical trials used filiform needles except for two articles (one used Fu’s subcutaneous needles, while another did not document the type of needle used).¹¹ Acupuncture frequency varied for the different articles, ranging from once a week to daily. Needle retention was uniform in the articles that documented this information: 30 min of acupuncture per session.

Characteristics of Safety

Most of the practitioners were qualified acupuncturists except for two articles, which did not state the qualifications of the practitioner. Adherence to clean needle technique was also largely not mentioned in most articles except for one case report. Indications for acupuncture in diabetic limbs were largely for diabetic foot (n = 6 articles), whereas two articles had indications for knee osteoarthritis or pain. Sites of intervention were all localized to the lower limb.

Outcomes

Table 3 showed that three articles highlighted adverse events and possible dangers related to needling in diabetic limbs. All three mentioned complications of subsequent infection (one even developed necrotizing fasciitis) resulting in surgical drainage. One article even resulted in below-knee amputation. The other five articles (one case study, three clinical trials, and one review) highlighted no serious adverse events in using acupuncture/needling in diabetic limbs (one trial reported some bleeding/pain post acupuncture, effects that were expected).

DISCUSSION

Safety Risk Factors

This scoping review had highlighted some factors that possibly influence the safety of acupuncture in diabetic limbs. Sterility of procedure and equipment remained paramount in determining possible adverse events of infection post acupuncture in diabetic feet. This could be seen in the case report by Saw, 2004 of which there was no skin disinfection and the sterility of the needle was highly questionable.⁷ The sterility of the other case reports that resulted in adverse events was not documented. Generally, most acupuncture practices should adopt clean needle technique. It includes handwashing in addition to skin preparation (cleaning with alcohol) and only holding the handle of the needle.¹⁵ This requirement should be even more stringent in diabetic feet, where any wound poses a higher risk of infection and complications.

The use of heat modalities with acupuncture was also highlighted as a possible high-risk factor for adverse events as seen in the case report by He, 2018.⁹ Sensory neuropathy often accompanies diabetic feet, resulting in heat injury on top of the acupuncture needle wound, as patients are likely insensate.¹⁶ This likely multiplies the chance of post treatment complications, especially during acupuncture coupled with heat modalities such as moxa-attached warm acupuncture, as with the case in He, 2018. The risk of complications is even higher when using a therapeutic heat lamp during acupuncture on diabetic patients taking photosensitizing drugs such as certain antibiotics, antifungals, antihistamines, non-steroidal anti-inflammatory drugs, and retinoids.

Another possible risk factor could be the type of needles used. As seen in the case report of Ede, 2008, there was a fragment left in situ post acupuncture posing as a nidus of infection. This exemplified the importance of using high-quality, durable needles that have a low risk of breakage in situ during treatment.

Treatment being administered by registered or certified practitioners might also be an important safety factor. In many parts of the world, acupuncture is considered a part of complementary and alternative medicine, which is often less regulated than mainstream medicine. As a result, it may sometimes be practiced by unqualified individuals, posing potential safety risks due to the possibility of unsafe practices.^17,18 A clear relationship between practitioner qualification status and complication risk could not be elucidated in this scoping review. However, it should be noted that for one of the case reports highlighting adverse events, the qualification status of the practitioner was not stated.⁸

Frequency and duration of needling did not appear to be safety risk factors. Among the three case reports with adverse events, only He, 2018 documented an acupuncture frequency of once a day for 1 week. The other two case reports did not elucidate this detail, while the other articles without adverse events had variable treatment frequency ranging from once daily to once per week.

Possible Benefits

Despite the risk of adverse events in needling diabetic feet, this scoping review also unraveled some possible benefits of improving diabetic foot complications through acupuncture. All three clinical trials and one of the case reports showed no post treatment infection adverse events and showed improvement in neuropathy symptoms¹¹ and diabetic foot ulcer healing.^10,13 Purported mechanisms included reducing inflammatory cytokines, stabilizing oxidative factors, improving local blood perfusion, and facilitating neovascularization and wound healing.^12,14

LIMITATIONS

The limited number of case reports and studies, as well as the relatively small number of participants in the included clinical trials, highlighted a need for larger population numbers to draw more robust conclusions. It might also signify either under-reporting of adverse events or a genuine low rate of adverse events globally. Also, our search databases were largely limited to Western databases. Future studies can include searching Asian databases, for example, Chinese databases, which may hold more articles about this topic.

CONCLUSION

Through this scoping review, we had identified possible risks of ulceration and poor healing resulting in infection and gangrene after treating diabetic feet with acupuncture. However, there were also likely benefits that could be reaped with acupuncture treatment, namely improving neuropathy symptoms and ulcer healing. It is therefore crucial to minimize safety risk factors by observing strict infection control, ensuring needle sterility and quality, avoiding use of concomitant heat modalities, and assuring treatment administered by qualified practitioners. Complication rates can then be minimized for patients to reap maximal benefits from acupuncture treatment in the diabetic foot. It is therefore not an absolute contraindication to administer acupuncture in diabetic feet, and most importantly to proceed with caution and awareness.

DATA AVAILABILITY STATEMENT

All data generated or analyzed during this study are included in this published article.

AUTHORS’ CONTRIBUTIONS

Y.H.: Conceptualization; data curation, formal analysis, investigation, methodology, project administration, writing—original draft preparation, review and editing. W.H.L.: Data curation, formal analysis, writing—review and editing. H.Y.Y.: Formal analysis; writing—review and editing.

AUTHOR DISCLOSURES STATEMENT

No competing financial interests exist.

FUNDING INFORMATION

No funding was received for this article.